Clinical Trials Directory

Trials / Completed

CompletedNCT00278395

Vorinostat in Treating Patients With Kidney Cancer

A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
14 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well vorinostat works in treating patients with advanced kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of vorinostat (SAHA), in terms of objective response and progression rate, in patients with advanced renal cell carcinoma. SECONDARY OBJECTIVES: I. Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in these patients. II. Evaluate overall survival, progression-free survival, and survival rate at 12 months in patients treated with this drug. III. Correlate changes in biologic measurements with outcomes of patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks at the discretion of the investigator. After completion of study treatment, patients are followed within 1 month and then approximately every 2 months thereafter.

Conditions

Interventions

TypeNameDescription
DRUGVorinostatGiven orally

Timeline

Start date
2005-10-01
Primary completion
2010-02-01
Completion
2010-02-01
First posted
2006-01-18
Last updated
2017-11-14
Results posted
2013-08-30

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00278395. Inclusion in this directory is not an endorsement.